Posts tagged ocular
Ocular Therapeutix gets complete response letter

Ocular Therapeutix (NASDAQ:OCUL) received a complete response letter (CRL) from the FDA about its NDA for DEXTENZA for intracanalicular use in the treatment of ocular pain occurring after ophthalmic surgery.

Concerns raised by the FDA pertain to deficiencies in manufacturing process and controls identified during a pre-NDA approval inspection of the company’s manufacturing facility. The FDA’s letter did not provide any details as to which manufacturing deficiencies remain open since the last response submitted by the company.

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BioLight expands portfolio with eye drops for DES

BioLight Life Sciences (TASE:BOLT) has obtained worldwide rights, excluding Israel and Italy, for the manufacturing, distribution, sales and marketing of a groundbreaking new eye drop product for the treatment of dry eye syndrome (DES) and other ophthalmic indications.

The product was in-licensed from Fischer Pharmaceuticals and RAMOT, the technology transfer arm of the Tel Aviv University.

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Ocular Therapeutix to initiate Phase 3 program with OTX-TP

Ocular Therapeutix (NASDAQ:OCUL) has completed an end-of-Phase 2 review with the FDA for its sustained release travoprost product candidate, OTX-TP, for the treatment of glaucoma and ocular hypertension and intends to initiate the first of two Phase 3 clinical trials during the third quarter of 2016.

The FDA has stated that it agrees with the overall Phase 3 clinical development program proposed by Ocular in its briefing package submitted to the FDA.

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